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Central Line ComplicationNCT03216824

CVAD-Associated Skin Impairment in Allogeneic Stem Cell Transplant Recipients: Dressing vs No-Dressing

A study testing Dressing and No-Dressing in people with Central Line Complication, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Central venous access device (CVAD)-associated skin impairment (CASI) is a common problem in allogeneic hematopoietic stem cell transplant (HSCT) recipients. In this prospective randomized pilot study, dressing the CVAD exit site will be compared to no-dressing with respect to CASI and CVAD-related bloodstream… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Central Line Complication
What is being tested?
Dressing and No-Dressing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteCanada
Study dates
14 Sep 2017to 4 Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to provide informed consent
  • 19 years of age or over
  • Recipient of an allogeneic HSCT (sibling, haploidentical, or unrelated donor) within the past 35-60 days
  • Receiving post-allogeneic HSCT follow-up care at the outpatient HSCT clinic at the study centre
  • Possessing a tunneled CVAD with cuff (either Hickman™, Leonard™ or Broviac™) inserted greater than 40 days prior to screening visit
  • An embedded T-CVAD exit site (i.e. subcutaneous tissue attached to the internal cuff and prior removal of the exit site suture)
  • Documented neutrophil engraftment
  • Free of temperature equal to or greater than to 38° C in the past seven days

Who cannot join

  • An infection requiring systemic IV therapy within the last seven days
  • A history of abdominal abscess or endocarditis
  • Active discharge and/or bleeding from the T-CVAD exit site
  • Severe CASI (i.e. greater than grade 3 as per the Modified ECOG Skin Toxicity Scale)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9.

Other trials in Canada

About this study

Official title: CVAD-Associated Skin Impairment: A Pilot Study Comparing Dressing to No-Dressing in Adult Allogeneic Stem Cell Transplant Recipients

Central venous access device (CVAD)-associated skin impairment (CASI) is a common problem in allogeneic hematopoietic stem cell transplant (HSCT) recipients. In this prospective randomized pilot study, dressing the CVAD exit site will be compared to no-dressing with respect to CASI and CVAD-related bloodstream infection (CRBSI) rates in adult outpatient HSCT recipients. The purpose of this study is to gain information that can be used to design a large randomized controlled trial (RCT).

Read the detailed description

Central venous access device (CVAD)-associated skin impairment (CASI) is common in adult allogeneic hematopoietic stem cell (HSCT) recipients. CASI is defined as chemical, mechanical or microbiological damage to the skin occurring within a 7 cm radius of a CVAD exit site. CASI is associated with discomfort, complex dressing changes, and increased infection risk due to disruption of skin barrier function. Allogeneic hematopoietic stem cell transplant (HSCT) recipients receiving post-transplant care in the outpatient HSCT setting may be at higher risk of CASI. No-dressing of embedded tunneled CVAD (T-CVAD) exit sites may decrease CASI without increased risk of CVAD-related bloodstream infection (CRBSI), but no studies have been conducted to test this hypothesis. A pilot study will determine the practicality of testing this hypothesis. The proposed pilot study will be conducted at an outpatient HSCT clinic located at a large tertiary hospital. The primary aim is to evaluate the logistics of comparing no-dressing to dressing in the outpatient adult allogeneic HSCT population. A total of 26 allogeneic HSCT recipients will be enrolled. Enrollment will commence once the following conditions are met: REB approval, institutional approval, and assignment of an NCT ID number. Eligible participants will have embedded T-CVADs, be within 35 to 60 days of transplant, meet criteria for neutrophil engraftment, and be without pre-existing severe CASI. Participants will be randomized to either a dressing or no-dressing group. A modified version of the Eastern Cooperative Oncology Group (ECOG) skin toxicity scale will be used to grade CASI at baseline and weekly for up to six weeks. Primary and secondary endpoints will be tested statistically to generate estimates of effect size and standard deviations, for the purpose of future study design. Information useful for planning large-scale studies will be reported, such as enrollment metrics, participant compliance, procedure fidelity, and missing data characteristics. Feedback will be collected from participants regarding their study experience.

Being tested
Dressing, No-Dressing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DressingOther

    A dressing is maintained on the CVAD exit site.

  • No-DressingOther

    The CVAD exit site is not covered with a dressing.

Study groups in NCT03216824
Study groupRoleWhat they receive
DressingActive comparatorA dressing is maintained on the CVAD exit site.
Receives: Other: Dressing
No-DressingExperimentalThe CVAD exit site is not covered with a dressing.
Receives: Other: No-Dressing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CVAD-associated skin impairment (CASI) rate

    CASI is defined as: chemical, mechanical or microbiological damage to the skin occurring within a 7 cm radius of a CVAD exit site (i.e. the "CASI boundary area"). Skin damage will be measured using a modified ECOG Skin Toxicity Scale. The scale has five levels of measurement with "0" = no CASI, and "1, 2, 3 and 4" corresponding to increasing levels of CASI severity. A finding of CASI of any severity will be counted as one episode of CASI. The rate of CASI will be reported as total CASI episodes.

    Measured: The first CASI assessment will occur within one week of randomization. CASI assessments will be conducted every seven days with up to six assessments in total (i.e. the study follow-up period is six weeks).

Secondary outcomes (2)

  1. CVAD-related bloodstream infection (CRBSI) rate

    CRBSI is defined as a bloodstream infection linked to a CVAD using a laboratory method with high sensitivity and specificity. In this study differential time to positivity (DTP) will be used to confirm CRBSI. Concomitant peripheral and CVAD blood cultures will be drawn at the new onset of a temperature equal to or greater than 38° C. A set of cultures in which the CVAD culture turns positive two or more hours before a positive peripheral culture will be considered one episode of CRBSI. The rate of CRBSI will be reported according to the number of CRBSI episodes per 1,000 catheter days.

    Measured: All episodes of CRBSI will be captured during the six week study follow-up period.

  2. Rate of moderate and severe CVAD-associated skin impairment (CASI)

    All episodes of CASI that meet the modified ECOG Skin Toxicity Scale criteria for levels 2, 3 or 4 will be included to calculate the rate of "moderate and severe" CASI.

    Measured: The first CASI assessment will occur within one week of randomization. CASI assessments will be conducted every seven days with up to six assessments in total.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2017
  2. Study start14 Sep 2017
  3. Primary completion4 Nov 2018
  4. Study completion4 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
One group will maintain a dressing on the CVAD exit site as per institutional practice. The second group will not cover the CVAD exit site with a dressing (i.e. no-dressing).
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03216824
Sponsor's protocol ID
H17-01002
Status last verified
Oct 2019
First submitted
31 May 2017
Last updated
14 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to make IPD available to other researchers.

Publications

  • Benhamou E, Fessard E, Com-Nougue C, Beaussier PS, Nitenberg G, Tancrede C, Dodeman S, Hartmann O. Less frequent catheter dressing changes decrease local cutaneous toxicity of high-dose chemotherapy in children, without increasing the rate of catheter-related infections: results of a randomised trial. Bone Marrow Transplant. 2002 Apr;29(8):653-8. doi: 10.1038/sj.bmt.1703511.

    PubMed 12180109

  • Broadhurst D, Moureau N, Ullman AJ; World Congress of Vascular Access (WoCoVA) Skin Impairment Management Advisory Panel. Management of Central Venous Access Device-Associated Skin Impairment: An Evidence-Based Algorithm. J Wound Ostomy Continence Nurs. 2017 May/Jun;44(3):211-220. doi: 10.1097/WON.0000000000000322.

    PubMed 28353488

  • Dix CH, Yeung DT, Rule ML, Ma DD. Essential, but at what risk? A prospective study on central venous access in patients with haematological malignancies. Intern Med J. 2012 Aug;42(8):901-6. doi: 10.1111/j.1445-5994.2011.02596.x.

    PubMed 21981058

  • Gillies D, O'Riordan E, Carr D, O'Brien I, Frost J, Gunning R. Central venous catheter dressings: a systematic review. J Adv Nurs. 2003 Dec;44(6):623-32. doi: 10.1046/j.0309-2402.2003.02852.x.

    PubMed 14651685

  • Keeler M. Central line practice in Canadian blood and marrow transplant. Can Oncol Nurs J. 2014 Spring;24(2):67-77. doi: 10.5737/1181912x2426771. English, French.

    PubMed 24902424

  • Keeler, M., Haas, B., Northam, S., Nieswiadomy, M., McConnel, C., & Savoie, L. Analysis of costs and benefits of transparent, gauze, or no dressing for a tunnelled central venous catheter in Canadian stem cell transplant recipients. Canadian Oncology Nursing Journal. 25(3): 289-298, 2015.

  • Lawrence JA, Seiler S, Wilson B, Harwood L. Shower and no-dressing technique for tunneled central venous hemodialysis catheters: a quality improvement initiative. Nephrol Nurs J. 2014 Jan-Feb;41(1):67-72; quiz 73.

    PubMed 24689266

  • Mimoz O, Lucet JC, Kerforne T, Pascal J, Souweine B, Goudet V, Mercat A, Bouadma L, Lasocki S, Alfandari S, Friggeri A, Wallet F, Allou N, Ruckly S, Balayn D, Lepape A, Timsit JF; CLEAN trial investigators. Skin antisepsis with chlorhexidine-alcohol versus povidone iodine-alcohol, with and without skin scrubbing, for prevention of intravascular-catheter-related infection (CLEAN): an open-label, multicentre, randomised, controlled, two-by-two factorial trial. Lancet. 2015 Nov 21;386(10008):2069-2077. doi: 10.1016/S0140-6736(15)00244-5. Epub 2015 Sep 18.

    PubMed 26388532

  • Nagai T, Kohsaka S, Anzai T, Yoshikawa T, Fukuda K, Sato T. Low incidence of catheter-related complications in patients with advanced pulmonary arterial hypertension undergoing continuous epoprostenol infusion. Chest. 2012 Jan;141(1):272-273. doi: 10.1378/chest.11-1893. No abstract available.

    PubMed 22215838

  • O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee (HICPAC). Guidelines for the prevention of intravascular catheter-related infections. Clin Infect Dis. 2011 May;52(9):e162-93. doi: 10.1093/cid/cir257. Epub 2011 Apr 1. No abstract available.

    PubMed 21460264

  • Olson K, Rennie RP, Hanson J, Ryan M, Gilpin J, Falsetti M, Heffner T, Gaudet S. Evaluation of a no-dressing intervention for tunneled central venous catheter exit sites. J Infus Nurs. 2004 Jan-Feb;27(1):37-44. doi: 10.1097/00129804-200401000-00006.

    PubMed 14734986

  • Orsino, L., Bargelli, A., Cappucciati, L., Fanchin, G., Galati, G., Manzin, F., ... Vendemiati, S. Observational study of SorbaView® 2000, SorbaView® ultimate and SecureView® port AFZ dressings used on central venous catheters in eleven italian oncology, hematology and pain centers. Journal of the Association for Vascular Access, 14(1): 14-19, 2009.

  • Petrosino B, Becker H, Christian B. Infection rates in central venous catheter dressings. Oncol Nurs Forum. 1988 Nov-Dec;15(6):709-17. No abstract available.

    PubMed 3144709

  • Laura R, Degl'Innocenti M, Mocali M, Alberani F, Boschi S, Giraudi A, Arnaud MT, Zucchinali R, Paris MG, Dallara R, Thaler S, Perobelli G, Parfazi S, De Lazzer T, Peron G. Comparison of two different time interval protocols for central venous catheter dressing in bone marrow transplant patients: results of a randomized, multicenter study. The Italian Nurse Bone Marrow Transplant Group (GITMO). Haematologica. 2000 Mar;85(3):275-9.

    PubMed 10702816

  • Renaud B, Brun-Buisson C; ICU-Bacteremia Study Group. Outcomes of primary and catheter-related bacteremia. A cohort and case-control study in critically ill patients. Am J Respir Crit Care Med. 2001 Jun;163(7):1584-90. doi: 10.1164/ajrccm.163.7.9912080.

    PubMed 11401878

Questions about this trial

What is this clinical trial studying?

A study testing Dressing and No-Dressing in people with Central Line Complication, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CVAD-associated skin impairment (CASI) rate (time frame: The first CASI assessment will occur within one week of randomization. CASI assessments will be conducted every seven days with up to six assessments in total (i.e. the study follow-up period is six weeks).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03216824, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2019.

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